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Rosa Antonijoan, Jimena Coimbra, Consuelo García-Gea, Montserrat Puntes, Ignasi Gich, Cristina Campo, Román Valiente, Luis Labeaga
OBJECTIVE: To compare the peripheral antihistaminic activity of bilastine, rupatadine and desloratadine in inhibiting the histamine-induced wheal and flare (W&F) response. RESEARCH DESIGN AND METHODS: Twenty-four healthy volunteers aged 18-40 years participated in this crossover, randomized, double-blind, placebo-controlled clinical study. Subjects received single doses of bilastine 20 mg, desloratadine 5 mg, rupatadine 10 mg and placebo. W&F responses induced by intradermal injection of histamine 5 μg were evaluated before treatment (basal value) and at 0...
October 21, 2016: Current Medical Research and Opinion
Lucia Grumetto, Antonio Del Prete, Giovanni Ortosecco, Antonella Borrelli, Salvatore Del Prete, Aldo Mancini
Background. We report a case of bilateral posterior subcapsular cataracts (PSCs) in a 24-year-old man with an allergic conjunctivitis history caused by a long-term therapy with glucocorticoids. Case Presentation. The patient showed a visual acuity of 9/10 for both eyes. He followed a therapy with ketotifen and bilastine for four years. During the last six months before our evaluation, he was treated with chloramphenicol and betamethasone, interrupted for onset of cataracts and increased intraocular pressure...
2016: Case Reports in Ophthalmological Medicine
Michihiro Hide, Akiko Yagami, Michinori Togawa, Akihiro Saito, Masutaka Furue
BACKGROUND: Bilastine, a novel non-sedating second-generation H1-antihistamine, has been widely used in the treatment of allergic rhinoconjunctivitis and urticaria with a recommended dose of 20 mg once daily in most European countries since 2010. We evaluated its efficacy and safety in Japanese patients with chronic spontaneous urticaria (CSU). METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled phase II/III study (trial registration No...
September 2, 2016: Allergology International: Official Journal of the Japanese Society of Allergology
Kimihiro Okubo, Minoru Gotoh, Michinori Togawa, Akihiro Saito, Yoshihiro Ohashi
OBJECTIVE: Bilastine is a novel second-generation antihistamine. This open-label, single-arm, phase III study evaluated the safety and efficacy of long-term treatment with bilastine in Japanese patients with seasonal (SAR) or perennial allergic rhinitis (PAR). METHODS: Patients with SAR or PAR who met the registration criteria and did not violate the exclusion criteria received bilastine (20mg, once daily) for 12 weeks (treatment period). Patients with PAR who met the transition criteria could elect to continue the bilastine treatment for an additional 40 weeks (continuous treatment period: a total of 52 weeks)...
August 22, 2016: Auris, Nasus, Larynx
Pierre J L Valk, Ries Simons, Andrea M Jetten, Román Valiente, Luis Labeaga
INTRODUCTION: Bilastine is a new oral, second generation antihistamine used in the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. It is considered a nonsedating antihistamine and might be recommended for use in pilots, pending research on the effects on flying-related performance under hypobaric conditions that prevail in an airliner. We assessed the effects of a single dose of bilastine 20 mg on alertness and complex task performance of healthy volunteers in a hypobaric chamber at 75...
July 2016: Aerospace Medicine and Human Performance
Michinori Togawa, Hidetoshi Yamaya, Mónica Rodríguez, Hirotaka Nagashima
BACKGROUND AND OBJECTIVES: Bilastine is a novel second-generation antihistamine for the symptomatic treatment of allergic rhinitis and urticaria. The objective of this study was to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of bilastine following single and multiple oral doses in healthy Japanese subjects. The pharmacokinetic and pharmacodynamic profiles were compared with those reported in Caucasian subjects. METHODS: In a single-blind, randomized, placebo-controlled, parallel-group, single- and multiple-ascending dose study, bilastine tablets were administered at single doses of 10, 20, and 50 mg (Part I), and once daily for 14 days at 20 and 50 mg (Part II)...
August 6, 2016: Clinical Drug Investigation
Kazuhiro Hashiguchi, Ken-Ichiro Wakabayashi, Michinori Togawa, Akihiro Saito, Kimihiro Okubo
BACKGROUND: Environmental exposure chambers have been used to expose subjects to aeroallergens to investigate the efficacy of prophylactic treatment with symptomatic agents in Japan. We first examined the therapeutic effect of bilastine (BIL), a novel non-sedative second-generation H1-antihistamine, in subjects with Japanese cedar pollinosis using an artificial exposure chamber (OHIO Chamber). METHODS: This was a randomized, double-blind, four-way crossover, placebo- and active-controlled phase II study (trial registration number JapicCTI-132213)...
July 27, 2016: Allergology International: Official Journal of the Japanese Society of Allergology
Kimihiro Okubo, Minoru Gotoh, Mikiya Asako, Yasuyuki Nomura, Michinori Togawa, Akihiro Saito, Takayuki Honda, Yoshihiro Ohashi
BACKGROUND: Bilastine, a novel non-sedating second-generation H1 antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR). METHODS: This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexofenadine (60 mg twice daily), or a matched placebo (double dummy) in patients with PAR...
July 12, 2016: Allergology International: Official Journal of the Japanese Society of Allergology
R B Locks, K Dos Santos, J da Silva
OBJECTIVES: The aim of this study was to determine whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg. DESIGN: This was a prospective randomised double-blinded study. SETTING: Otolaryngology outpatient clinics in Criciúma, state of Santa Catarina, Brazil. PARTICIPANTS: Seventy-three patients, aged between 18 and 63 years, of whom 36 were treated with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for 10 days...
July 6, 2016: Clinical Otolaryngology
J Sánchez, J Zakzuk, R Cardona
BACKGROUND: Antihistamines are the first line of treatment for chronic spontaneous urticaria. However, there is no effective method to predict whether an antihistamine will have a beneficial clinical effect or not. OBJECTIVE: To assess whether the change in histamine-induced wheal and flare measurements 24 hours after administration of antihistamine can predict the efficacy of treatment. METHODS: We performed a multicenter, triple-blind, randomized study...
2016: Journal of Investigational Allergology & Clinical Immunology
Jelena Terzić, Igor Popović, Ana Stajić, Anja Tumpa, Biljana Jančić-Stojanović
This paper deals with the development of hydrophilic interaction liquid chromatographic (HILIC) method for the analysis of bilastine and its degradation impurities following Analytical Quality by Design approach. It is the first time that the method for bilastine and its impurities is proposed. The main objective was to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Critical process parameters which have the most influence on method performance were defined as acetonitrile content in the mobile phase, pH of the aqueous phase and ammonium acetate concentration in the aqueous phase...
June 5, 2016: Journal of Pharmaceutical and Biomedical Analysis
Xue Yan Wang, Margaret Lim-Jurado, Narayanan Prepageran, Pongsakorn Tantilipikorn, De Yun Wang
Allergic rhinitis and urticaria are common allergic diseases that may have a major negative impact on patients' quality of life. Bilastine, a novel new-generation antihistamine that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action. This agent does not interact with the cytochrome P450 system and does not undergo significant metabolism in humans, suggesting that it has very low potential for drug-drug interactions, and does not require dose adjustment in renal impairment...
2016: Therapeutics and Clinical Risk Management
Zoltán Novák, Anahí Yáñez, Ildikó Kiss, Piotr Kuna, Miguel Tortajada-Girbés, Román Valiente
BACKGROUND: Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10-mg dose of bilastine in children aged 2 to <12 years provided an equivalent systemic exposure as 20 mg in adults. The current study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria. METHODS: In this phase III, multicentre, double-blind study, children were randomized to once-daily treatment with bilastine 10-mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks...
August 2016: Pediatric Allergy and Immunology
Ralph Mösges, Dennis Lip Yen Lee, Jovilia Abong, Bella Siasoco, Steven Kw Chow, Jern-Lin Leong, Harvinder Singh, S Kuljit, Benjamin Campomanes
The prevalence of allergic diseases is increasing globally, most particularly in middle- to low-income countries. This article examines the burden of allergic rhinitis and chronic urticaria in the Asia-Pacific region, unmet clinical needs, and the potential role of bilastine in the management of these conditions. An International Advisory Group meeting was convened in association with the Asian Pacific Society of Respirology Annual Congress in November 2014, followed by a literature review, and consensus-based outcomes from the meeting and literature review are described...
January 2016: Asia Pacific Allergy
Ignacio Jáuregui, Johannes G Ramaekers, Kazuhiko Yanai, Magí Farré, Esther Redondo, Román Valiente, Luis Labeaga
INTRODUCTION: Rational selection of a second-generation H1-antihistamine requires efficacy and safety considerations, particularly regarding central nervous system (CNS) effects (cognitive and psychomotor function), potential for driving impairment, minimal sedative effects and a lack of interactions. This review evaluates the key safety features of the non-sedating antihistamine, bilastine, during driving and in preventing road traffic accidents. AREAS COVERED: Among the second-generation H1-antihistamines, sedative effects which can affect cognitive and psychomotor performance, and possibly driving ability, may not be similar...
January 2016: Expert Opinion on Drug Safety
Désirée Larenas-Linnemann, Mario Sánchez-Borges, Blanca Estela Del Río-Navarro, María De Lourdes Alonzo-Romero Pareyón, César Alfonso Maldonado-García, Enrique Mendoza-López, José Antonio Ortega-Martell, Juan José Luis Sienra-Monge, Miguel Alejandro Medina-Ávalos, María Isabel Rojo-Gutiérrez, Angélica María Beirana-Palencia, Jorge Bernardo Vargas-Correa, Carlos Báez-Loyola, Ruth Ivonne Mireya Ramírez-Segura, María Graciela Guzmán-Perea
There are four types of histamine receptors. Allergic symptoms, especially those in rhinoconjunctivitis and urticaria, are mainly caused by activation of histamine receptor 1 (H1). Consequently, oral H1-antihistamines form and integral part of the treatment of these diseases. Antihistamines are inverse agonists that stabilize the non-active configuration of the histamine receptor. First generation H1-antihistamines cause a variety of adverse effects via several mechanisms: sedation (accumulation in the central nervous system), dry mouth, urinary retention, weight gain (low selectivity: stimulation of serotonin/muscarinic/alpha-adrenergic receptors) and drug interactions (substrate of CYP450-3A4)...
July 2015: Revista Alergia Mexico: Organo Oficial de la Sociedad Mexicana de Alergia e Inmunología, A.C
Erminia Ridolo, Marcello Montagni, Laura Bonzano, Cristoforo Incorvaia, Giorgio Walter Canonica
Bilastine is a new second generation H1-antihistamine recently approved for the symptomatic treatment of allergic rhinitis (AR) and chronic urticaria (CU). Bilastine epitomizes the evolution of research on antihistamines concerning both efficacy and safety. In AR treatment, a number of large controlled clinical trials documented its efficacy, as assessed by improvement of all nasal and ocular symptoms and quality of life. These outcomes show that bilastine meets current EAACI/ARIA criteria for medications used in the treatment of AR...
2015: Clinical and Molecular Allergy: CMA
María Luisa Lucero, Armin Peither, Francisco Ledo
CONTEXT: Bilastine is a new oral selective, non-sedating histamine H1 antagonist for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. The European Medicines Agency requires an Environmental Risk Assessment (ERA) for all novel medicines for human use. OBJECTIVE: To calculate the bilastine predicted environmental concentration in surface water (PECsw; phase I ERA), and to determine the effects of bilastine on aquatic systems (phase II [tier A])...
October 2015: Drug and Chemical Toxicology
Krzysztof Kowal, Lawrence DuBuske
BACKGROUND: Allergic rhinitis is a very frequent disease. H1 antihistamines have been used for treatment of allergic rhinitis for more than 5 decades. They differ in chemical structure, pharmacokinetics, pharmacodynamics, clinical efficacy and adverse effects. METHODS: We performed a detailed analysis of all available publications concerning the new H1-antihistamine bilasitine. RESULTS: Bilastine, a piperidine derivative, is a novel potent H1 antihistamine...
July 2014: American Journal of Rhinology & Allergy
Magí Farré, Clara Pérez-Mañá, Esther Papaseit, Esther Menoyo, Marta Pérez, Soraya Martin, Santiago Bullich, Santiago Rojas, José-Raúl Herance, Carlos Trampal, Luis Labeaga, Román Valiente
AIM: A close correlation exists between positron emission tomography (PET)-determined histamine H1 -receptor occupancy (H1 RO) and the incidence of sedation. Antihistamines with H1 RO <20% are classified as non-sedating. The objective was to compare the H1 RO of bilastine, a second generation antihistamine, with that of hydroxyzine. METHODS: This randomized, double-blind, crossover study used PET imaging with [(11) C]-doxepin to evaluate H1 RO in 12 healthy males (mean age 26...
November 2014: British Journal of Clinical Pharmacology
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